Sitagil M 50/500 ER Tablet

What is Sitagil M?

Sitagil M ER is a fixed-dose combination of Sitagliptin and extended-release Metformin Hydrochloride manufactured by Incepta Pharmaceuticals Ltd. It combines two complementary mechanisms to control blood glucose in type 2 diabetes mellitus, offering the convenience of once-daily dosing with two active ingredients in a single tablet.

Generic Name and Composition

Each extended-release tablet contains 50 mg of Sitagliptin (as phosphate monohydrate) and 500 mg of Metformin Hydrochloride.

Indications

• Type 2 diabetes mellitus in patients not adequately controlled on metformin or sitagliptin monotherapy
• For patients already being treated with both sitagliptin and metformin separately, as a more convenient combined regimen

How It Works — Mechanism of Action

Sitagliptin inhibits the DPP-4 enzyme, increasing incretin hormone levels to enhance glucose-dependent insulin secretion and reduce glucagon release. Metformin reduces hepatic glucose production and improves peripheral insulin sensitivity. Together, they provide complementary glucose-lowering effects.

Dosage and Administration

• Dosage is individualized by a physician based on current sitagliptin and metformin doses.
• Typically taken once daily with the evening meal; swallow whole, do not crush, split, or chew.
• Take with food to reduce gastrointestinal side effects.
• Do not change the dose without consulting your physician.

Side Effects

Common: Diarrhea, nausea, abdominal discomfort, headache, upper respiratory tract infection — often related to the metformin component, especially at treatment start.

Uncommon: Hypoglycemia (especially when combined with sulfonylureas or insulin), vitamin B12 deficiency with long-term use.

Rare: Lactic acidosis, pancreatitis, severe hypersensitivity reactions, bullous pemphigoid (skin blistering).

Drug Interactions

May enhance hypoglycemia: Insulin, sulfonylureas.

May increase metformin levels / risk of lactic acidosis: Iodinated contrast media.

Other considerations: Alcohol may increase risk of lactic acidosis; inform your doctor of all medicines you are taking.

Contraindications

• Known hypersensitivity to sitagliptin, metformin, or any excipient
• Severe renal impairment
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis
• Conditions predisposing to tissue hypoxia (e.g., severe heart failure, respiratory failure)

Pregnancy and Lactation

Use during pregnancy and breastfeeding should only be under medical supervision; insulin is often preferred for tight glycemic control in pregnancy. Discuss the risks and benefits with your physician.

Precautions and Warnings

• Temporarily discontinue before procedures using iodinated contrast media, as advised by your physician.
• Seek medical attention immediately for symptoms of pancreatitis or lactic acidosis.
• Use with caution in elderly patients and those with impaired kidney or liver function.
• Monitor renal function periodically during long-term therapy.

Overdose

Overdose may cause hypoglycemia (from sitagliptin component) or lactic acidosis (from metformin component). This is a medical emergency requiring immediate hospitalization with supportive care and, if needed, hemodialysis.

Storage Instructions

• Store below 30°C in a dry place, protected from light.
• Keep out of reach of children.
• Do not use after the expiry date printed on the pack.

Frequently Asked Questions

Q1: Why is Sitagil M ER taken once daily instead of multiple times?
The extended-release formulation releases both active ingredients gradually, allowing once-daily dosing with generally better gastrointestinal tolerance.

Q2: Can I switch from separate Sitagil and Nobesit tablets to Sitagil M ER?
Yes, under physician guidance, switching to a combination tablet matching your current doses can simplify your regimen.

Q3: Will Sitagil M ER cause low blood sugar?
The combination carries a low intrinsic hypoglycemia risk, which increases if combined with insulin or sulfonylureas.

Q4: How does the 50/500 strength differ from Sitagil M 100/1000?
Both contain the same active ingredients; the 100/1000 strength is a higher dose used for patients needing greater glucose control, as determined by your physician.

Medical Disclaimer

This product is available by prescription only (Rx). The information provided is for educational purposes and does not replace professional medical advice. Always consult a registered physician before starting, stopping, or changing any diabetes therapy. DiabetesStore.com.bd is a licensed online pharmacy in Bangladesh.